1. Field of the Invention
The present invention relates generally to medicament administration. More particularly, the invention concerns a novel fluid medicament delivery apparatus that is specially designed to facilitate the aseptic administration of drugs to patients.
2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98
Medicaments intended for parenteral administration are typically stored in a medicament container in either in liquid, powdered or lyophilized form. Typically, lyophilized drugs are packaged in standard glass vials that are sealed with a pierceable rubber stopper and a crimped metal cap. A suitable liquid diluent must be added to the vial to reconstitute the powdered or lyophilized drug before use. In accordance with typical prior art methods, this reconstitution step was accomplished by drawing a measured amount of diluent, such as water, into a syringe from a diluent vial. The sealed vial containing the powdered or lyophilized drug was then accessed using a hypodermic needle and syringe to add the liquid diluent to the vial. The vial was then in inverted and shaken to intermix the drug with the liquid diluent. This done, the reconstituted drug was withdrawn into the syringe and was injected into the patient.
It is apparent that when reconstitution of a drug is required, the prior art processes required at least two fluid transfers. The problem of ensuring proper fluid transfer under acceptable aseptic conditions during these two fluid transfers was formidable and was especially acute in the case of self-administration of drugs by patients in a homecare environment. For example, during the fluid transfers, the rubber stopper that is disposed within the top of the vial must be penetrated by the syringe needle. Typically, the rubber stopper is not sterile and, accordingly, the exposed needle is exposed to non-sterile conditions. Furthermore, as the needle penetrates the rubber stopper it will inevitably become contaminated with small particles of rubber that are dislodged from the rubber stopper during the needle penetration step. Additionally, this two-step process is quite cumbersome for physicians and particularly for homecare caregivers to accomplish, often under the stressful conditions that frequently exist at the bedside of a patient.
One approach to overcoming the drawbacks of the prior art methods as described in the preceding paragraphs is disclosed in U.S. Pat. No. 6,238,372 to issued to Zinger et al. The Zinger et al. patent discloses a drug vial mixing and transfer device having one or more ports with interconnecting fluid passageways. The ends of the ports are attached either to a piercing connector or a syringe. The piercing connector is used to support and penetrate the rubber stoppers of the standard glass drug vials that are filled with powdered or lyophilized drugs or a liquid diluent during the transfer of the liquid diluent and drug solutions between the vials and the syringe. In one form of the invention, the ports and connectors are mounted on a base and a stopcock type valve is used to coordinate communication between the fluid passageways of the different ports. Retainers mounted on the base hold the syringe and vials in place during the liquid transfer operations.